Pilot Study of ALLTogether Consortium Treatment for Infants, Children, and Young Adults Aged 0 to 45 with Newly Diagnosed Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a master protocol designed to improve survival and quality of life for infants, children, and young adults aged 0 to 45 years who have been newly diagnosed with acute lymphoblastic leukemia ALL. This observational pilot study collects data from multiple well-known study groups, combining their experience into a comprehensive system for stratifying and treating ALL within this age group. The study aims to optimize diagnostics, registration systems, and collaborative logistics before the main study begins, focusing on standard of care treatments included in the master protocol. The study does not involve specific experimental interventions but serves as a platform for personalized risk-based diagnosis and treatment approaches. It includes standard treatments delivered at participating pediatric oncology or adult hematology centers in the involved countries. High-risk patients may be considered for specialized therapies such as Chimeric Antigen Receptor T-cell CAR-T therapy as an alternative to more intensive treatments to reduce side effects. The platform supports randomized and non-randomized interventions and translational research within the collaboration. Participants will be monitored through regular clinical assessments, with data collected on event-free survival and overall survival compared to historical controls over five years. The study involves confirmation of diagnosis by accredited laboratories, ongoing treatment at participating centers, and adherence to protocol procedures. This pilot phase focuses on collecting data and preparing the infrastructure for future randomized trials and extended research. Participants remain under their usual care throughout the study period, which spans several years for outcome evaluation.

A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia